COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52251

Kshitij Mody

drkshitijmody@welcarehospital.co.in

2021-02-03

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Subjects who meet all of the following criteria will be included in the study: <br/ > <br/ >1) Age: Adult 18 years inclusive and above at the time of consent. <br/ >2) Sex: Adult, healthy males and non-pregnant/non-lactating females. <br/ >3) Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects including absence of symptom or signs of Covid-19 infection or any other ILI. <br/ >4) Subjects must be able to understand and provide written informed consent to participate in the study. <br/ >5) Subjects with no relevant findings in medical history or on physical examination which would suggest to the P.I. that the subject is unsuitable for inclusion in the study. <br/ >6) Subjects who are willing to allow the Investigator to register volunteer details with a confidential database (The - Over-Volunteering Protection Service) to prevent concurrent entry into clinical studies/trials. <br/ >7) Subjects who are able and willing to comply with all the trial requirements.

Subjects who meet any of the following criteria will be excluded from the study: <br/ > <br/ >1) Subjects who have a clinically significant active Oral Cavity disease. <br/ >2) Subjects who have a history of recent Oral ongoing treatment. <br/ >3) Subjects who have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. <br/ >4) Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. <br/ >5) Subjects who are currently participating in any another study related to Oral applications. <br/ >6) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study or have participated in a clinical study in the recent past up to three months. <br/ >7) Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated. <br/ >8) Subjects who are Pregnant, lactating or have the intention to become pregnant during trial period as determined by questioning the subject. <br/ >9) Subjects with any pharyngeal, or laryngeal finding which precludes bronchoscopy.

2

Myself Health Check Ltd

18

90

India

Healthy volunteers

N/A

325

The proportion of subjects not getting ILI symptoms at the end of the study using the Flu-Pro Plus Patient Reported Outcome Measure (PROM).Timepoint: 28 days

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1213, "treatment_name": "Sodium bicarbonate", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]